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Cocaine DependenceNCT01038232

Measuring Distress Tolerance With Functional MRI

An observational study of Cocaine Dependence, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: People who are in treatment for substance abuse often feel distress during the withdrawal period and afterward. Some individuals feel distress more acutely than others, and this distress has been linked to poor treatment outcomes and increased risk of relapse in smokers, alcoholics, and cocaine- and… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Cocaine Dependence
How many people
99 participants
Where
2 sitesUnited States
Study dates
4 Dec 2009to 24 Mar 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Be between the ages of 18 and 55.
  • Be in good health.
  • Be right-handed.
  • Cocaine dependent participants: Endorse regular cocaine use (i.e., greater than or equal to 2 times per week) in the past year.
  • Non-drug using controls: will be matched to the cocaine using participants with respect to age, gender, IQ, socioeconomic factors, and years of education.

Who cannot join

  • Pregnant. Urine pregnancy tests will be performed on all female volunteers of child-bearing age before each experimental session.
  • Have implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or claustrophobia rendering them unable to undergo fMRI scanning.
  • Have major medical illnesses to include, but not limited to, hypertension, cardiovascular disease, asthma, diabetes, peripheral vascular diseases, coagulopathies, syncope, history of superficial or deep vein thrombosis, HIV, or other clinically significant infectious diseases.
  • Have current major psychiatric disorders to include, but not limited to, mood, anxiety, borderline personality disorder, psychotic disorders, or substance-induced psychiatric disorders,
  • Have neurological illnesses including, but not limited to, seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor.
  • Control participants: Meet DSM-IV criteria for any past or current substance abuse or dependence; use of illicit substances in the last 30 days or nicotine if use is greater than 10 cigarettes per day and/or Fagerstrom score is greater than 3.
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  • Cocaine using participants:
  • Non-treatment subjects: Meet DSM-IV criteria for substance dependence on any substance other than nicotine or cocaine in the month prior to study enrollment. Only (except nicotine or cocaine dependence will be allowed in the month prior to enrollment. Current abuse on any substance will be acceptable.). While it might be preferable to exclude individuals whose use of other substances reaches the threshold of abuse, inclusion of such individuals will not necessarily contaminate the data.
  • Inpatient cocaine subjects: Those who meet DSM-IV TR criteria for the course specifier In a Controlled Environment may have a history of dependence on substances other than cocaine before their admission to the inpatient treatment program.
  • Regular use of any prescription, over-the-counter, or herbal medication that may alter CNS function, cardiovascular function or neuronal-vascular coupling. Medications that could interfere with the BOLD signal include compounds that have been shown to be vasoactive, including alpha agonists, beta blockers, and calcium channel blockers.
  • Have cognitive impairment as assessed by screening WASI vocabulary subtest below 48, corresponding to full IQ of 85 (in that case on screening, a full WASI will be done to verify IQ of 85 or above).
  • Acute drug intoxication or positive urine drug screen at the beginning of the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • National Institute on Drug Abuse, Biomedical Research Center (BRC)

    Baltimore, Maryland, 21224

  • University of Maryland, College Park

    College Park, Maryland

Other trials in United States

About this study

Background:

  • People who are in treatment for substance abuse often feel distress during the withdrawal period and afterward. Some individuals feel distress more acutely than others, and this distress has been linked to poor treatment outcomes and increased risk of relapse in smokers, alcoholics, and cocaine- and heroin-dependent individuals. More research is needed on the effects of distress on the brain, particularly in individuals who are seeking treatment for substance abuse. Researchers are interested in using functional magnetic resonance imaging (fMRI) scanning to study distress tolerance in both substance users seeking treatment and healthy non-drug-using volunteers.
Read more

Objectives:

  • To use functional magnetic resonance imaging to study the effectiveness of a distress tolerance assessment.

Eligibility:

  • Individuals between 18 and 50 years of age who are either cocaine dependent or healthy non-drug-using volunteers.

Design:

  • This study involves an initial screening visit and a scanning visit, with four followup visits.
  • Participants will be screened with a medical history and physical examination, as well as blood samples and questionnaires about mood and past and current drug use.
  • Participants will have a structural MRI scan of the brain to provide a baseline reading for comparison. Participants will then have an fMRI scanning session, which will include both the distress tolerance assessment and relevant control tasks. Heart rate, blood pressure, and other physical reactions will be monitored throughout the scan. Participants will also provide blood and saliva samples to measure stress hormone levels.
  • Participants will be eligible to have followup assessments with fMRI scanning 1, 3, 6, and 12 months after the scanning visit.
Read the detailed description

Objective: The primary objective of the current study is to implement a distress tolerance assessment for use in fMRI to determine the neurobiological differences between individuals with low and high distress tolerance. Additionally, other biological and physiological indicators will be assessed, including genetic polymorphisms, salivary cortisol, galvanic skin response, and blood pressure. The overall hypothesis is that individuals with low distress tolerance will exhibit hyperactivation in the extended amygdala and hypoactivation of the prefrontal cortex and anterior cingulate cortex when experiencing affective distress and failure during a stressful task, as compared to individuals with high distress tolerance.

Study Population: The study population will consist of healthy male and female adult volunteers (18-55 years old), as well as an otherwise healthy sample of male and female treatment seeking substance users with cocaine users (18-55 years old) (see exclusion criteria).

Experimental Design and Methods: After being medically cleared and giving written informed consent, each participant will undergo a structural MRI scan of the brain, and undergo an fMRI scanning session, which will include administration of the distress tolerance and relevant control tasks. Physiological response to the tasks, including heart rate, blood pressure, galvanic skin conductance, and salivary cortisol concentrations will be monitored throughout the fMRI scan. Follow-up assessments on control and cocaine dependent participants will occur at 1, 3, 6, and 12 months after the baseline assessment. Genetic data collected under the aegis of protocol 10-DA-N457 will be compared with data collected under this study.

Outcome Measures: Outcome measures include distress tolerance measured as latency in seconds to task termination on each of the distress tolerance tasks, neural indices of distress tolerance (for all participants), and substance use treatment outcomes (for cocaine users) including relapse to drug use, latency to first cocaine use, and number of substance use days per week at follow-ups.

Keywords
Distress Tolerance, Cocaine Dependence, Relapse, Limbic System, Prefrontal Cortex, Healthy Volunteer, HV
Medical subject headings
Cocaine-Related Disorders, Recurrence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To identify neural indices of distress tolerance using fMRI in healthy non-drug users, and examine the relationship between these neural indices and important physiological, biological, and behavioral correlates of distress tolerance.

Secondary outcomes (1)

  1. To determine if neural processes associated with distress tolerance predict sustained abstinence among treatment seeking cocaine dependent participants following 1, 3, 6, and 12 months follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2009 (estimated)
  2. Study start4 Dec 2009
  3. Study completion24 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Other
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01038232
Sponsor's protocol ID
999910453
Other IDs
10-DA-N453
Status last verified
24 Mar 2015
First submitted
19 Dec 2009
Last updated
12 Dec 2019
Results posted
No

Publications

  • Abercrombie HC, Schaefer SM, Larson CL, Oakes TR, Lindgren KA, Holden JE, Perlman SB, Turski PA, Krahn DD, Benca RM, Davidson RJ. Metabolic rate in the right amygdala predicts negative affect in depressed patients. Neuroreport. 1998 Oct 5;9(14):3301-7. doi: 10.1097/00001756-199810050-00028.

    PubMed 9831467

  • Ahmed SH, Koob GF. Cocaine- but not food-seeking behavior is reinstated by stress after extinction. Psychopharmacology (Berl). 1997 Aug;132(3):289-95. doi: 10.1007/s002130050347.

    PubMed 9292629

  • Acker C. Neuropsychological deficits in alcoholics: the relative contributions of gender and drinking history. Br J Addict. 1986 Jun;81(3):395-403. doi: 10.1111/j.1360-0443.1986.tb00346.x. No abstract available.

    PubMed 3461848

Questions about this trial

What is this clinical trial studying?

An observational study of Cocaine Dependence, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To identify neural indices of distress tolerance using fMRI in healthy non-drug users, and examine the relationship between these neural indices and important physiological, biological, and behavioral correlates of distress tolerance.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01038232, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.

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